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The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental |
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| Treatment 2 | Experimental |
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| Treatment 3 | Experimental |
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| Treatment 4 | Placebo Comparator |
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| Treatment 5 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 Eye drops | Drug | Ophthalmic topical solution, low dose, dosed once/day, 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Staining Scores for Study Eye From Baseline | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ichinomiya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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In this study, during the 2-week run-in period, enrolled participants were administered artificial tears 4 times daily after signing informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | CP-690,550 Eye Drops Vehicle Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| CP-690,550 Eye drops |
| Drug |
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks |
|
| CP-690,550 Eye drops | Drug | Ophthalmic topical solution, high dose, dosed once/day, 8 weeks |
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| CP-690,550 Eye drops-vehicle | Drug | Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks |
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| Sodium Hyaluronate | Drug | Ophthalmic topical solution, dosed 6 times/day, 8 weeks |
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| Baseline, Week 1, 2 and 4 |
| Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 1, 2, 4 and 8 |
| Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 1, 2, 4 and 8 |
| Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 1, 2, 4 and 8 |
| Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. | Week 1, 2, 4 and 8 |
| Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Baseline, Week 1, 2, 4 and 8 |
| Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 1, 2, 4 and 8 |
| Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 8 |
| Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 8 |
| Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 8 |
| Number of Participants With Ocular Adverse Events (AEs)by Severity | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category. | 8 weeks |
| Number of Participants With Nonocular Adverse Events (AEs) by Severity | Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. | 8 weeks |
| Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | 8 weeks |
| Baseline, Week 4 and 8 |
| Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | Baseline, Week 4 and 8 |
| Narashino |
| Chiba |
| Japan |
| Pfizer Investigational Site | Urayasu | Chiba | Japan |
| Pfizer Investigational Site | Fukuoka | Fukuoka | Japan |
| Pfizer Investigational Site | Chiba | Japan | Japan |
| Pfizer Investigational Site | Tokyo | Japan | Japan |
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan |
| Pfizer Investigational Site | Yokohama | Kangawa | Japan |
| Pfizer Investigational Site | Kyoto | Kyoto | Japan |
| Pfizer Investigational Site | Osaka | Osaka | Japan |
| Pfizer Investigational Site | Fuji | Shizuoka | Japan |
| Pfizer Investigational Site | Numazu | Shizuoka | Japan |
| Pfizer Investigational Site | Shizuoka | Shizuoka | Japan |
| Pfizer Investigational Site | Susono | Shizuoka | Japan |
| Pfizer Investigational Site | Chiyoda-ku | Tokyo | Japan |
| Pfizer Investigational Site | Hamura | Tokyo | Japan |
| Pfizer Investigational Site | Minato-ku | Tokyo | Japan |
| Pfizer Investigational Site | Ohta-ku | Tokyo | Japan |
| Pfizer Investigational Site | Sumida-ku | Tokyo | Japan |
| Pfizer Investigational Site | Tachikawa | Tokyo | Japan |
| Pfizer Investigational Site | Taito-ku | Tokyo | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| Pfizer Investigational Site | Gwangju | 501-757 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Seoul | 136-705 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Seoul | South Korea |
| FG001 |
| CP-690,550 Eye Drops 0.001% Group in Japan |
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| FG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| FG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| FG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| FG005 | CP-690,550 Eye Drops Vehicle Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| FG006 | CP-690,550 Eye Drops 0.001% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| FG007 | CP-690,550 Eye Drops 0.003% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| FG008 | CP-690,550 Eye Drops 0.005% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
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| ID | Title | Description |
|---|---|---|
| BG000 | CP-690,550 Eye Drops Vehicle Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG001 | CP-690,550 Eye Drops 0.001% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| BG005 | CP-690,550 Eye Drops Vehicle Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG006 | CP-690,550 Eye Drops 0.001% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG007 | CP-690,550 Eye Drops 0.003% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG008 | CP-690,550 Eye Drops 0.005% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 8 |
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| Secondary | Changes in Corneal Staining Scores for Study Eye From Baseline | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2 and 4 |
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| Secondary | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8. | Posted | Number | Percentage of participants | Week 1, 2, 4 and 8 |
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| Secondary | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Seconds | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Millimeters | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8. | Posted | Number | Percentage of participants | Week 1, 2, 4 and 8 |
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| Secondary | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Number | Participants | Week 1, 2, 4 and 8 |
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| Secondary | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Number | Participants | Week 1, 2, 4 and 8 |
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| Secondary | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4 and 8 |
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| Secondary | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. | Posted | Number | Percentage of participants | Week 1, 2, 4 and 8 |
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| Secondary | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Week 8 |
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| Secondary | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Week 8 |
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| Secondary | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Intent-to-treat population: Participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Week 8 |
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| Secondary | Number of Participants With Ocular Adverse Events (AEs)by Severity | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety analysis set: Participants who received at least 1 dose of study treatment. | Posted | Number | Participants | 8 weeks |
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| Secondary | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety analysis set: Participants who received at least 1 dose of study treatment. | Posted | Number | Participants | 8 weeks |
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| Secondary | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | Safety analysis set: Participants who received at least 1 dose of study treatment. | Posted | Number | Participants | 8 weeks |
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| Other Pre-specified | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline. | A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8. | Posted | Mean | Standard Deviation | Antibodies bound per cell | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8. | Posted | Mean | Standard Deviation | Percentage of positive cells | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 and 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | mcg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | Relative unit/mL | Baseline, Week 4 and 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. | Posted | Number | Participants | Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | Relative unit/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | Relative unit/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | mcg/mL | Baseline, Week 4 and 8 |
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| Other Pre-specified | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. | A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. | Posted | Mean | Standard Deviation | mcg/mL | Baseline, Week 4 and 8 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP-690,550 Eye Drops Vehicle Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 0 | 41 | 11 | 41 | ||
| EG001 | CP-690,550 Eye Drops 0.001% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 0 | 42 | 11 | 42 | ||
| EG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 2 | 41 | 16 | 41 | ||
| EG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 0 | 40 | 8 | 40 | ||
| EG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | 0 | 39 | 9 | 39 | ||
| EG005 | CP-690,550 Eye Drops Vehicle Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 0 | 21 | 6 | 21 | ||
| EG006 | CP-690,550 Eye Drops 0.001% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 0 | 19 | 7 | 19 | ||
| EG007 | CP-690,550 Eye Drops 0.003% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 1 | 21 | 6 | 21 | ||
| EG008 | CP-690,550 Eye Drops 0.005% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 0 | 21 | 8 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctival erosion | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Salivary gland pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Adenoviral conjunctivitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| High density lipoprotein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Optic nerve cup/disc ratio increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Between 45 and 64 years |
|
| >=65 years |
|
| Male |
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| CP-690,550 Eye Drops 0.003% Group in Japan |
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| OG005 | CP-690,550 Eye Drops Vehicle Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG006 | CP-690,550 Eye Drops 0.001% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG007 | CP-690,550 Eye Drops 0.003% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG008 | CP-690,550 Eye Drops 0.005% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
|
|
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| OG005 | CP-690,550 Eye Drops Vehicle Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG006 | CP-690,550 Eye Drops 0.001% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG007 | CP-690,550 Eye Drops 0.003% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG008 | CP-690,550 Eye Drops 0.005% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
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|
| CP-690,550 Eye Drops 0.003% Group in Japan |
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| OG005 | CP-690,550 Eye Drops Vehicle Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG006 | CP-690,550 Eye Drops 0.001% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG007 | CP-690,550 Eye Drops 0.003% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG008 | CP-690,550 Eye Drops 0.005% Group in Korea | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 |
| CP-690,550 Eye Drops 0.003% Group in Japan |
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 |
| CP-690,550 Eye Drops 0.003% Group in Japan |
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| CP-690,550 Eye Drops 0.003% Group in Japan |
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
|
|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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|
| OG002 | CP-690,550 Eye Drops 0.003% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG003 | CP-690,550 Eye Drops 0.005% Group in Japan | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| OG004 | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
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